A little less than a year after it reported the final close of a series D financing, Miracor Medical SA, of Awans, Belgium, has been granted breakthrough device designation by the U.S. FDA for its Pressure-Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse System for the treatment of ST-elevated myocardial infarction (STEMI) patients.
The failure of Novartis AG's Entresto in a phase III clinical trial staggered the stock (NASDAQ:NVS) somewhat Monday, down just 1.14%, but the real trauma may well be the loss of roughly $2.5 billion in anticipated sales.